Electric Breast Pump BLA-8015
by Ningbo Huiyoo Baby Products Co., Ltd.
Electric Breast Pump BLA-8015 is a Class II device made by Ningbo Huiyoo Baby Products Co., Ltd., cleared under FDA 510(k) K191802 on 16 Jan 2020 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 06972562618013), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06972562618013 | Date27 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191802 | Date16 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 06972562618013
- FDA 510(k) database K191802
Across registries
- FDA 510(k) K191802 decided 16 Jan 2020 Active
- FDA GUDID UDI-DI 06972562618013 listed 27 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K191802
- Listed FDA GUDID 06972562618013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Electric Breast Pump
- Generic name
- Breast pump, electric
- Model / reference
- BLA-8015
- Primary DI / UDI-DI
- 06972562618013
- 510(k) Number
- FDA product code
- HGX
- GMDN term
- Breast pump, electric
- Device class
- Class II
- Regulation number
- 884.5160
- GUDID distribution status
- In Commercial Distribution
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